- In a large primary prevention trial on low-dose aspirin in diabetics,
Japanese investigators report that daily aspirin did not have a significant
benefit in preventing the primary endpoints of all atherosclerotic events,
although it did protect against fatal heart attack and stroke.

- Low-dose aspirin was also associated with a reduced risk of fatal and
non-fatal atherosclerotic events, but only in a subgroup of diabetics who
were over age 65.

NEW ORLEANS, Nov. 11 /PRNewswire-USNewswire/ -- Type 2 diabetics
treated with low-dose aspirin did not have a significantly lower incidence
of atherosclerotic events than those who received placebo in this primary
prevention trial of low-dose aspirin, according to research presented at
the American Heart Association's Scientific Sessions 2008. However,
sub-group analyses showed a significant reduction with aspirin in both
atherosclerotic events in those over 65 years of age, and a reduction in
cerebrocardiovascular deaths. Results from The Japanese Primary Prevention
of Atherosclerosis with Aspirin for Diabetes (JPAD) trial were presented as
a late-breaking clinical trial. The study was simultaneously published in
the Journal of the American Medical Association.

"Our results indicate that aspirin is effective and safe for primary
prevention of cardiac and cerebrocardiovascular death in diabetics," said
Hisao Ogawa, M.D, Ph.D., lead investigator of the study and a professor of
cardiovascular medicine at Kumamoto University, Kumamoto, Japan, and chief
of the division of cardiology at the Kumamoto University Hospital. "In
addition, it offers a low-cost approach."

The randomized trial included 2,539 type 2 diabetics at 163 Japanese
medical centers.

In a subgroup analysis, the researchers found an association between
daily low-dose aspirin use and a 32 percent reduced relative risk for all
atherosclerotic events, both fatal and non-fatal, but only for diabetics
over age 65. In other words, individuals over age 65 who took aspirin had a
hazard ratio of 0.68 compared to those who did not take aspirin.

During an average of 4.4 years of follow-up, 154 atherosclerotic events
occurred, both fatal and non-fatal (68 in the aspirin group, 86 in the
non-aspirin group.) Those events included one fatal cardiovascular event (a
hemorrhagic stroke) in the aspirin group and 10 fatal strokes or heart
attacks in the non-aspirin group, Ogawa said.

Researchers found a large, statistically significant risk reduction for
fatal coronary and cerebrovascular events in the aspirin group vs. the
non-aspirin group (hazard ratio of 0.10.) But the confidence interval on
that finding was wide (CI=0.01 to 0.8), indicating a need for further
study, he said.

Diabetes is considered one of the strongest risk factors for
cardiovascular events. Aspirin therapy is commonly used for primary
prevention in diabetic patients in the United States and Canada, but not in
Japan, Ogawa said.

Several earlier studies have established the benefits of aspirin
therapy in preventing second cardiac events. However, its use for primary
prevention in diabetics, i.e., prevention in patients without a history of
cardiovascular disease, has been controversial because of the lack of data
indicating benefits and because aspirin carries a risk of gastric bleeding,
Ogawa said.

He said aspirin was well tolerated as demonstrated by the comparable
number of the combined endpoint of serious hemorrhagic events (hemorrhagic
strokes and major gastrointestinal bleeds).

In comparing bleeding events, the researchers reported 13 hemorrhagic
strokes, with no statistically significant difference between aspirin
takers and non-takers (six such strokes in the aspirin group; seven in the
non-aspirin group).

On the other hand, the total number of all hemorrhagic events was
greater in the aspirin group compared to the non-aspirin group (34 vs. 10
such events). Four patients in the aspirin group had bleeding events that
required transfusion. Furthermore, those in the aspirin group had more
gastrointestinal symptoms (55 cases vs. eight cases), but all cases were
resolved without surgery and no fatalities occurred, he said.

"Our findings need to be interpreted in the context of the low
incidence of atherosclerotic disease in Japan," Ogawa said. "We conclude
that aspirin as primary prevention is beneficial at least for fatal heart
attack and fatal stroke in our entire study group and for all
atherosclerotic disease among those age 65 or over."

The study was funded by Japan's Ministry of Health, Labour and Welfare.

Statements and conclusions of study authors that are presented at
American Heart Association scientific meetings are solely those of the
study authors and do not necessarily reflect association policy or
position. The association makes no representation or warranty as to their
accuracy or reliability. The association receives funding primarily from
individuals; foundations and corporations (including pharmaceutical, device
manufacturers and other companies) also make donations and fund specific
association programs and events. The association has strict policies to
prevent these relationships from influencing science content. Revenues from
pharmaceutical and device corporations are available at
http://www.americanheart.org/corporatefunding.

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